As is known, a patient information leaflet consists of a sheet of paper, normally folded on itself several times so it fits easily into the medicine pack.
Generally speaking, current health regulations in different countries determine the information that must be provided in the leaflet to define the ingredients, doses and usage of the medicine.
For example, the following is printed on both sides of the patient information leaflet: the brand name (name of the drug), a brief description of the active ingredient and copyright information; the company that manufactures and/or distributes the drug, including details of how the company can be contacted; how the drug works and must be used, including warnings and precautions for its proper use; dosage and administration, when and how the drug should be taken, including possible results of overdosage or related problems; the expiry date and general warnings regarding the risks incurred if the drug is not used properly.
As mentioned above, the patient information leaflet consists of a single sheet of paper, precisely because this ensures that the user will have ready access to all the information about the medicine on a single piece of paper. That means none of the information about the drug will be lost because it is all on one sheet.
The size and number of folds of the patient information leaflet depend on the amount of information it contains and on the size of the medicine pack.
An example of an information insert is described in patent documents EP 0 900 671 and EP 1 818 301.
These documents describe an insert made from a single sheet which is suitably folded so it fits into a pack.
These information inserts, however, have one major drawback, due mainly to the limited amount of space available for all the information about the medicine.
To overcome this drawback, the information is printed in a very small font size so that as much information as possible can be squeezed into the available space.
This solution, however, in turn has the major disadvantage that the very small print is very difficult to read.
Patent document U.S. 2004/209754 describes an information item comprising a pair of information items, that is, a first information item and a second information item which are folded and coupled to each other.
It should be noticed that one of the information items (either the first or the second) of the pair of information items is a sheet which is suitably folded and then coupled to the sheet constituting the other information item of the pair of information items.
Coupling is accomplished as a result of folding the sheets.
The first item normally addresses medical staff, while the second item addresses the patient.
In light of this, this information item does not overcome the drawbacks described above.
In this context, the technical purpose which forms the basis of the present invention is to propose a medicine information insert which overcomes the above mentioned drawbacks of the prior art and which facilitates reading of the leaflet's contents in view also of recent European regulations on this subject, which require leaflet font size to be enlarged in order to improve legibility. Obviously, that would entail printing the information on a larger sheet of paper.
In effect, the solution to the problem of font size might be that of using sheets of paper which are much larger than those commonly and normally used today.
That would mean, in some cases, having to change existing printing technology (to use printing cylinders with larger transversal dimensions: printing width).
That would actually be less of a problem than having to also change sheet folding technology (where the sheet is folded, as is currently the case, so it will fit into the carton containing the medicine). In effect, that problem, irrespective of whether the technology for folding very large sheets currently exists or not, would involve a series of onerous investments both for companies (converters) who print and fold the information leaflets and for pharmaceutical companies themselves, where the latter receive the printed sheets from external sources and fold them using their in-house medicine packaging machinery.
In particular, this invention has for an aim to provide a medicine information insert able to provide sufficient space to contain all the necessary information about the medicine, even when the font size used is not particularly small.
Another aim of the invention is to provide a medicine information insert composed of a single body in order to prevent parts, if any, of the insert from being involuntarily separated.